Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC
A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy
| Condition(s) | Recurrent Nasopharyngeal Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy |
| Who can participate | Inclusion Criteria: 1. Pathologically diagnosed with recurrent nasopharyngeal carcinoma; 2. Resectable disease staging rT2 (deep parapharyngeal space, or distance to the internal carotid ≤5mm) or rT3 (excluding the lesions confined to the basal wall of sphenoid sinus), rT4, according to AJCC 8th edition; 3. Cervical lymph node metastasis can be controlled locally; 4. Aged 18 to 75 years; 5. Informed consent forms signed to participate in the trial; 6. Without distant metastasis; 7. ≥6months from the accomplishment of radical radiation to recurrence 8. previously only 1 course of radiotherapy; 9. Sufficient organ function; 10. ECOG score 0-2 and can tolerate surgery,chemotherapy and immunotherapy. Exclusion Criteria: 1. Participate in other interventional clinical trials; 2. Uncontrolled il |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Eye & ENT Hospital of Fudan University |
| Locations | Shanghai, Shanghai Municipality, China; Fuzhou, China; Nanning, China; Shanghai, China; Shanghai, China; Shanghai, China (+1 more sites) |
| Start date | 2024-07-09 |
| NCT ID | NCT06235203 |
| Official listing | https://clinicaltrials.gov/study/NCT06235203 |